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Androgel Side Effects

Common Androgel Side Effects


The most commonly reported Androgel side effects (click to view or check a box to report):

Blood Testosterone Decreased (608)
Asthenia (213)
Fatigue (201)
Blood Testosterone Increased (113)
Prostatic Specific Antigen Increased (106)
Incorrect Dose Administered (102)
Acne (101)
Blood Testosterone Abnormal (95)
Weight Increased (93)
Libido Decreased (93)
Alopecia (87)
Erectile Dysfunction (82)
Arthralgia (77)
Insomnia (73)
Dyspnoea (73)
Rash (71)
Pain (70)
Hair Growth Abnormal (70)
Headache (66)
Therapeutic Response Unexpected (66)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Androgel Side Effects Reported to FDA

The following Androgel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Androgel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Pulmonary Embolism, Deep Vein Thrombosis
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: blood testosterone decreased, who was treated with Androgel (dosage: 2 Pumps Ea. Arm Once Daily Applied To A Surface, Usually The Skin, start time: Jun 01, 2008), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Pulmonary Embolism
  • Deep Vein Thrombosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel treatment in male patients, resulting in pulmonary embolism side effect. The patient was hospitalized.

Cerebral Thrombosis, Brain Injury
This report suggests a potential Androgel Cerebral Thrombosis, Brain Injury side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: thrombosis and used Androgel (dosage: NA) starting Jan 28, 2014. Soon after starting Androgel the patient began experiencing various side effects, including:
  • Cerebral Thrombosis
  • Brain Injury
Drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cerebral thrombosis, may still occur.

Pulmonary Embolism, Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
This Pulmonary Embolism, Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress problem was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased. On NS this consumer started treatment with Androgel (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Androgel, the patient experienced the following unwanted symptoms/side effects:
  • Pulmonary Embolism
  • Thrombosis
  • Impaired Work Ability
  • Pain
  • Anxiety
  • Physical Disability
  • Emotional Distress
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as pulmonary embolism, may become evident only after a product is in use by the general population.

Cerebrovascular Accident, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety, Physical Disability, Emotional Distress
This is a report of a 53-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: blood testosterone decreased and was treated with Androgel (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Cerebrovascular Accident
  • Deep Vein Thrombosis
  • Impaired Work Ability
  • Pain
  • Anxiety
  • Physical Disability
  • Emotional Distress
The patient was hospitalized. This opens a possibility that Androgel treatment could cause the above reactions, including cerebrovascular accident, and some male subjects may be more susceptible.


Pneumonia, Atrial Fibrillation, Dyspnoea, Pallor
A 64-year-old male patient (weight: NA) from US with the following symptoms/conditions: blood testosterone decreased,vitamin supplementation,gastrooesophageal reflux disease,blood cholesterol increased started Androgel treatment (dosage: NA) on Jun 12, 2013. Soon after starting Androgel treatment, the subject experienced various side effects, including:
  • Pneumonia
  • Atrial Fibrillation
  • Dyspnoea
  • Pallor
Concurrently used drugs:
  • Cholecalciferol
  • Omeprazole
  • Simvastatin
  • Sildenafil Fibrate
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Androgel.

Myocardial Infarction, Physical Disability, Emotional Distress, Pain, Loss Of Employment
A 45-year-old patient from US (weight: NA) experienced symptoms, such as: blood testosterone decreased and was treated with Androgel(dosage: NA). The treatment was initiated on 201301. After that a consumer reported the following side effect(s):
  • Myocardial Infarction
  • Physical Disability
  • Emotional Distress
  • Pain
  • Loss Of Employment
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Androgel efficacy: NA.

Pain, Anxiety, Physical Disability, Emotional Distress, Pulmonary Embolism, Impaired Work Ability
In this report, Androgel was administered for the following condition: blood testosterone decreased.A 54-year-old male consumer from US (weight: NA) started Androgel treatment (dosage: Multiple Doses) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pain
  • Anxiety
  • Physical Disability
  • Emotional Distress
  • Pulmonary Embolism
  • Impaired Work Ability
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Androgel treatment could be related to the listed above side effect(s).

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This is a report of the following Androgel side effect(s):
  • Physical Disability
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
  • Deep Vein Thrombosis
  • Pulmonary Embolism
A 56-year-old male patient from US (weight: NA) presented with the following condition: blood testosterone decreased and received a treatment with Androgel (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Androgel treatment could be associated with the listed above side effect(s).

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This Androgel report was submitted by a 42-year-old male consumer from US (weight: NA). The patient was diagnosed with: blood testosterone decreased and Androgel was administered (dosage: Multiple Doses) starting: NS. The consumer developed a set of symptoms:
  • Physical Disability
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
  • Deep Vein Thrombosis
  • Pulmonary Embolism
Other drugs used simultaneously: NA.The patient was hospitalized.Those unexpected symptoms could be linked to a Androgel treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety, Deep Vein Thrombosis, Pulmonary Embolism
This is a report of a possible correlation between Androgel use and the following symptoms/side effect(s):
  • Physical Disability
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
  • Deep Vein Thrombosis
  • Pulmonary Embolism
which could contribute to an assessment of Androgel risk profile.A 54-year-old male consumer from US (weight: NA) was suffering from blood testosterone decreased and was treated with Androgel (dosage: NA) starting NS.Other concurrent medications: NA.The patient was hospitalized.

Cerebrovascular Accident, Physical Disability, Emotional Distress, Pain, Loss Of Employment, Pulmonary Embolism
A 74-year-old male patient from US (weight: NA) presented with the following symptoms: blood testosterone decreased and after a treatment with Androgel (dosage: NA) experienced the following side effect(s):
  • Cerebrovascular Accident
  • Physical Disability
  • Emotional Distress
  • Pain
  • Loss Of Employment
  • Pulmonary Embolism
The treatment was started on NS. Androgel was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Androgel consumers.

Pulmonary Embolism, Thrombosis, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
In this report, a 39-year-old male patient from US (weight: NA) was affected by a possible Androgel side effect.The patient was diagnosed with blood testosterone decreased. After a treatment with Androgel (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Pulmonary Embolism
  • Thrombosis
  • Physical Disability
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Androgel treatment.

Cerebrovascular Accident, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This is a report of a 57-year-old male patient from US (weight: NA), who used Androgel (dosage: NA) for a treatment of blood testosterone decreased. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Cerebrovascular Accident
  • Physical Disability
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
The following drugs could possibly have interacted with the Androgel treatment NA.The patient was hospitalized.Taken together, these observations suggest that a Androgel treatment could be related to side effect(s), such as Cerebrovascular Accident, Physical Disability, Emotional Distress, Impaired Work Ability, Pain, Anxiety.

Cerebrovascular Accident, Hemiplegia
This cerebrovascular accident side effect was reported by a consumer or non-health professional from US. A 58-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Androgel (dosage: NA), which was started on NS. Concurrently used drugs: NA. When starting to take Androgel the consumer reported the following symptoms:
  • Cerebrovascular Accident
  • Hemiplegia
The patient was hospitalized. These side effects may potentially be related to Androgel.

Myocardial Infarction
This is a Androgel side effect report of a 60-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: hypogonadism, who was treated with Androgel (dosage:NA, start time: NS), combined with:
  • Duloxetine
  • Clonazepam
  • Fish Oil
, and developed a serious reaction and a myocardial infarction side effect. The patient presented with:
  • Myocardial Infarction
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Androgel treatment in male patients suffering from hypogonadism, resulting in myocardial infarction.

Physical Disability, Pulmonary Embolism, Emotional Distress, Deep Vein Thrombosis, Impaired Work Ability, Pain, Anxiety
This report suggests a potential Androgel physical disability side effect(s) that can have serious consequences. A 60-year-old male patient from US (weight:NA) was diagnosed with the following health condition(s): blood testosterone decreased and used Androgel (dosage: Multiple Doses) starting NS. Soon after starting Androgel the patient began experiencing various side effects, including:
  • Physical Disability
  • Pulmonary Embolism
  • Emotional Distress
  • Deep Vein Thrombosis
  • Impaired Work Ability
  • Pain
  • Anxiety
Drugs used concurrently:NA. The patient was hospitalized. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as physical disability, may still occur.

Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This physical disability problem was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): blood testosterone decreased.On NS a consumer started treatment with Androgel (dosage: Multiple Doses). The following drugs/medications were being taken at the same time: NA. When commencing Androgel, the patient experienced the following unwanted symptoms /side effects:
  • Physical Disability
  • Pulmonary Embolism
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as physical disability, may become evident only after a product is in use by the general population.

Physical Disability, Pulmonary Embolism, Emotional Distress, Impaired Work Ability, Pain, Anxiety
This is a Androgel side effect report of a 54-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: blood testosterone decreased and was treated with Androgel (dosage: Multiple Doses) starting NS. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Physical Disability
  • Pulmonary Embolism
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
The patient was hospitalized. This opens a possibility that Androgel could cause physical disability and that some male patients may be more susceptible.

Physical Disability, Deep Vein Thrombosis, Emotional Distress, Impaired Work Ability, Pain, Anxiety
A 46-year-old male patient (weight: NA) from US with the following symptoms: blood testosterone decreased started Androgel treatment (dosage: Multiple Doses) on NS. Soon after starting Androgel treatment, the consumer experienced several side effects, including:
  • Physical Disability
  • Deep Vein Thrombosis
  • Emotional Distress
  • Impaired Work Ability
  • Pain
  • Anxiety
. Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Androgel side effects, such as physical disability.

Pulmonary Embolism
This pulmonary embolism side effect was reported by a consumer or non-health professional from US. A 50-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Androgel (dosage: 4 Pumps Daily; Applied To A Surface, Usually The Skin), which was started on Jan 01, 2010. Concurrently used drugs: NA..When starting to take Androgel the consumer reported symptoms, such as:
  • Pulmonary Embolism
These side effects may potentially be related to Androgel. The patient was hospitalized and became disabled.

Chest Pain, Pulmonary Thrombosis
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Androgel 1 % (dosage: 2 Pumps Per Day Applied To A Surface, Usually The Skin, start time: Jan 01, 2004), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Chest Pain
  • Pulmonary Thrombosis
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Androgel 1 % treatment in male patients, resulting in chest pain side effect. The patient was hospitalized and became disabled.

Prostatic Specific Antigen Increased, Biopsy Prostate Abnormal
This report suggests a potential Androgel Prostatic Specific Antigen Increased, Biopsy Prostate Abnormal side effect(s) that can have serious consequences. A 62-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hypogonadism and used Androgel (dosage: NA) starting NS. Soon after starting Androgel the patient began experiencing various side effects, including:
  • Prostatic Specific Antigen Increased
  • Biopsy Prostate Abnormal
Drugs used concurrently: NA. Although Androgel demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as prostatic specific antigen increased, may still occur.

Tendon Rupture, Bundle Branch Block Right, Pain In Extremity, Limb Injury
This Tendon Rupture, Bundle Branch Block Right, Pain In Extremity, Limb Injury problem was reported by a physician from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: blood testosterone decreased,hypertension,blood cholesterol increased,migraine,vitamin supplementation. On 201311 this consumer started treatment with Androgel (dosage: 4 Pumps). The following drugs were being taken at the same time:
  • Amlodipine
  • Simvastatin
  • Sumatriptan
  • Multivitamin
  • Fish Oil
  • Baby Aspirin
When commencing Androgel, the patient experienced the following unwanted symptoms/side effects:
  • Tendon Rupture
  • Bundle Branch Block Right
  • Pain In Extremity
  • Limb Injury
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as tendon rupture, may become evident only after a product is in use by the general population.

Arterial Occlusive Disease
This is a report of a 75-year-old male patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Androgel (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Arterial Occlusive Disease
This opens a possibility that Androgel treatment could cause the above reactions, including arterial occlusive disease, and some male subjects may be more susceptible.

Abdominal Pain, Gallbladder Perforation, Appendicitis, Cholecystitis, Abdominal Infection, Unevaluable Event, Musculoskeletal Pain, Pain In Extremity
A 40-year-old male patient (weight: NA) from COUNTRY NOT SPECIFIED with the following symptoms/conditions: blood testosterone decreased started Androgel treatment (dosage: 2 Pumps Daily) on 2013. Soon after starting Androgel treatment, the subject experienced various side effects, including:
  • Abdominal Pain
  • Gallbladder Perforation
  • Appendicitis
  • Cholecystitis
  • Abdominal Infection
  • Unevaluable Event
  • Musculoskeletal Pain
  • Pain In Extremity
Concurrently used drugs:
  • Testosterone
  • Amitriptyline
  • Elavil
  • Robaxin
  • Xanax
  • Effexor
  • Wellbutrin (Took 15 Pills)
  • Buprenorphine
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Androgel.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Androgel Side Effects

    Did You Have a Androgel Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Androgel for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Androgel Safety Alerts, Active Ingredients, Usage Information

    NDC0051-8425
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameAndrogel
    NameTestosterone
    Dosage FormGEL
    RouteTRANSDERMAL
    On market since20110314
    LabelerAbbVie Inc.
    Active Ingredient(s)TESTOSTERONE
    Strength(s)10
    Unit(s)mg/g
    Pharma ClassAndrogen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]

    Androgel Dosage, Warnings, Usage.

    Side Effects reported to FDA: 2967

    Androgel safety alerts: 2009

    Reported deaths: 32

    Reported hospitalizations: 249

    Testosterone gel products (AndroGel 1% and Testim 1% )

    Audience: Urological and Endocrinological healthcare professionals, pediatricians 

    [Posted 05/07/2009] FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the productsâ?? labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. Despite the currently labeled precautions, FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review. Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido and aggressive behavior. The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. FDA has provided recommendations and precautions to minimize the potential for secondary exposure.

    [May 07, 2009 - News Release - FDA]

    [May 07, 2009 - Testosterone Gel Safety Information Page - FDA]

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